Heart anchor positioning devices, methods, and systems for treatment of congestive heart failure and other conditions

ABSTRACT

According to one embodiment, a heart anchor tensioning device includes a main body and an elongate shaft. A tension member or tether may be inserted through a lumen of the elongate shaft to allow the shaft to be advanced over the tension member and within a body while the main body is positioned outside of the body. The device also includes an anchor coupling mechanism that is configured to engage a heart anchor and move the heart anchor into engagement with a first wall of the heart. The anchor coupling mechanism is able to lock the heart anchor to inhibit proximal movement of the heart anchor along the tension member. The device further includes a tension indicating mechanism that provides an indication of a force being applied to the heart anchor by the device.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to Provisional U.S. Patent ApplicationNo. 61/872,568 filed Aug. 30, 2013, entitled “Heart Anchor PositioningDevices, Methods, and Systems for Treatment of Congestive Heart Failureand Other Conditions,” the entire disclosure of which is herebyincorporated by reference, for all purposes, as if fully set forthherein.

BACKGROUND OF THE INVENTION

The present invention is related to improved medical devices, systems,and methods, with many embodiments being particularly useful forreducing the distance between two points in tissue in a minimally orless invasive manner. Specific reference is made to the treatment of afailing heart, particularly the alleviation of congestive heart failureand other progressive heart diseases. The provided devices, systems, andmethods will often be used so as to resize or alter the geometry of aventricle in a failing heart, such as by reducing its radius ofcurvature through the process of excluding a portion of thecircumference from contact with blood, and thereby reduce wall stress onthe heart and improve the heart's pumping performance. Although specificreference is made to the treatment of congestive heart failure,embodiments of the present invention can also be used in otherapplications in which tissue geometry is altered.

Exemplary embodiments described herein provide implants and methods foralleviating congestive heart failure and other progressive diseases ofthe heart. Congestive heart failure may, for example, be treated usingone or more implants which are selectively positioned relative to afirst wall of the heart (typically an interventricular septum), andanother wall of the heart so as to exclude scar tissue and limit a crosssectional area, or distance across a ventricle. Functional deteriorationof the heart tissues may be inhibited by decreasing a size of the heartchamber and/or approximating tissues so that stress on the tissues islimited. Implant locations and overall chamber remodeling achieved byplacement of a series of implants may be determined so as to provide abeneficial volumetric decrease and chamber shape.

Congestive heart failure (sometimes referred to as “CHF” or “heartfailure”) is a condition in which the heart does not pump enough bloodto the body's other organs. Congestive heart failure may in some casesresult from narrowing of the arteries that supply blood to the heartmuscle, high blood pressure, heart valve dysfunction due to degenerativeprocesses or other causes, cardiomyopathy (a primary disease of theheart muscle itself), congenital heart defects, infections of the hearttissues, and the like. However, in many cases congestive heart failuremay be triggered by a heart attack or myocardial infarction. Heartattacks can cause scar tissue that interferes with the heart muscle'shealthy function, and that scar tissue can progressively replace moreand more of the contractile heart tissue. More specifically, thepresence of the scar may lead to a compensatory neuro-hormonal responseby the remaining, non-infarcted myocardium leading to progressivedysfunction and worsening failure.

People with heart failure may have difficulty exerting themselves, oftenbecoming short of breath, tired, and the like. As blood flow out of theheart decreases, pressure within the heart increases. Not only doesoverall body fluid volume increase, but higher intracardiac pressureinhibits blood return to the heart through the vascular system. Theincreased overall volume and higher intracardiac pressures result incongestion in the tissues. Edema or swelling may occur in the legs andankles, as well as other parts of the body. Fluid may also collect inthe lungs, interfering with breathing (especially when lying down).Congestive heart failure may also be associated with a decrease in theability of the kidneys to remove sodium and water, and the fluid buildupmay be sufficient to cause substantial weight gain. With progression ofthe disease, this destructive sequence of events can cause theprogressive deterioration and eventual failure of the remainingfunctional heart muscle.

Treatments for congestive heart failure may involve rest, dietarychanges, and modified daily activities. Various drugs may also be usedto alleviate detrimental effects of congestive heart failure, such as bydilating expanding blood vessels, improving and/or increasing pumping ofthe remaining healthy heart tissue, increasing the elimination of wastefluids, and the like.

Surgical interventions have also been applied for treatment ofcongestive heart failure. If the heart failure is related to an abnormalheart valve, the valve may be surgically replaced or repaired.Techniques also exist for exclusion of the scar and volume reduction ofthe ventricle. These techniques may involve (for example) surgical leftventricular reconstruction, ventricular restoration, the Dor procedure,and the like. If the heart becomes sufficiently damaged, even moredrastic surgery may be considered. For example, a heart transplant maybe the most viable option for some patients. These surgical therapiescan be at least partially effective, but typically involve substantialpatient risk. While people with mild or moderate congestive heartfailure may benefit from these known techniques to alleviate thesymptoms and/or slow the progression of the disease, less traumatic, andtherefore, less risky therapies which significantly improve the heartfunction and extend life of congestive heart failure patients hasremained a goal.

It has been proposed that an insert or implant be used to reduceventricular volume of patients with congestive heart failure. Withcongestive heart failure, the left ventricle often dilates or increasesin size. This can result in a significant increase in wall tension andstress. With disease progression, the volume within the left ventriclegradually increases and blood flow gradually decreases, with scar tissueoften taking up a greater and greater portion of the ventricle wall. Byimplanting a device which brings opposed walls of the ventricle intocontact with one another, a portion of the ventricle may be excluded orclosed off. By reducing the overall size of the ventricle, particularlyby reducing the portion of the functioning ventricle chamber defined byscar tissue, the heart function may be significantly increased and theeffects of disease progression at least temporarily reversed, halted,and/or slowed.

BRIEF SUMMARY OF THE INVENTION

The present invention generally provides improved medical devices,systems, and methods. Exemplary embodiments of the devices are describedfor use in reducing the distance between a region along the septum and aregion of an external wall of the left ventricle of a heart in a less orminimally invasive manner. According to one embodiment, a heart anchorpositioning device is provided. The heart anchor positioning deviceincludes a main body and an elongate shaft having a proximal end that iscoupled with the main body and a distal end and a lumen extendingbetween the proximal end and the distal end. A tension member isinsertable through the lumen to enable the device to be advanced overthe tension member so that the distal end is insertable within a bodyand adjacent the heart while the main body is positioned outside of thebody.

The heart anchor positioning device also includes an anchor couplingmechanism that is positioned at the distal end of the elongate shaft.The anchor coupling mechanism is configured to engage a heart anchor tomove the heart anchor distally and proximally along the tension memberand into engagement with a first wall of the heart so as to urge thefirst wall toward a second wall of the heart. The anchor couplingmechanism is also configured to lock the heart anchor to inhibitproximal movement of the heart anchor along the tension member. Theheart anchor positioning device further includes a tension indicatingmechanism that is configured to indicate a force being applied to theheart anchor by the device.

In some embodiments, the main body includes a locking mechanism that isactuatable by a user to lock the heart anchor to inhibit proximalmovement of the heart anchor along the tension member and to unlock theheart anchor to allow proximal and distal movement of the heart anchoralong the tension member. In such embodiments, the elongate shaft mayinclude a pair of hooks. The pair of hooks may be axially moveablerelative to a pin disposed at a distal end of the elongate shaft.Proximal movement of the pair of hooks relative to the pin may engagethe pin with a cam component of the heart anchor to unlock the heartanchor.

In some embodiments, the tension indicating mechanism may be operable ina first mode and a second mode. In the first mode, the tensionindicating mechanism may allow the device to engage the heart anchor tourge the first wall toward the second wall without indicating the forcebeing applied by the device. In the second mode, the tension indicatingmechanism may indicate the force being applied to the heart anchor bythe device. In such embodiments, in the first mode, the elongate shaftmay be stationary relative to the main body as the force is applied tothe heart anchor by the device. In the second mode, the elongate shaftmay be moveable axially relative to the main body as the force isapplied to the heart anchor by the device.

Further, in such embodiments, the elongate shaft may be coupled to asecondary body that is disposed within the main body. The secondary bodymay engage a spring component that is positioned within the main bodyand that allows the secondary body to move axially within the main bodyin the first mode. The main body may include a button component orlocking mechanism that is actuatable by a user to switch the tensionindicating mechanism from the first mode to the second mode to inhibitaxial movement of the secondary body within the main body. The secondarybody may include indicia that indicates the force being applied to theheart anchor by the device as the secondary body is moved axiallyrelative to the main body.

According to another embodiment, a method for securing heart anchors ofa heart implant device is provided. The method includes positioning afirst anchor in engagement with a first wall of the heart, where thefirst anchor is coupled with a tension member. The method also includespositioning a second anchor in engagement with a second wall of theheart. The second anchor is slidably coupled with the tension member sothat the second anchor may slide proximally and distally along a lengthof the tension member. The method further includes advancing atensioning device over the tension member so that a distal end of thetensioning device engages the second anchor while a main body of thetensioning device is positioned outside of the body. The methodadditionally includes applying a desired anchor force between thetension member and the second anchor via the tensioning device so thatthe first anchor provides a force urging the first wall toward thesecond wall and the second anchor provides a force urging the secondwall toward the first wall. During the application of the anchor force,the tensioning device may provide an indication of the anchor forceapplied to the second anchor by the tensioning device. The method mayadditionally include actuating a locking mechanism of the tensioningdevice to secure the second anchor to the tension member to restrictproximal movement of the second anchor along the tension member.

In some embodiments, actuating the locking mechanism of the tensioningdevice may reconfigure the second anchor from a variable force mode thatallows the second anchor to slide proximally and distally along thetension member to a set force mode that restricts proximal movement ofthe second anchor along the tension member. In such embodiments,actuating the locking mechanism of the tensioning device may move a pairof hooks axially relative to a pin that is positioned on a distal end ofan elongate shaft of the tensioning device. Movement of the pair ofhooks relative to the pin may engage the pin with a cam component of thesecond anchor.

In some embodiments, the method may additionally include advancing thesecond anchor distally along the tension member with the tensioningdevice in a first mode of operation, where the first mode of operationallows the tensioning device to engage the second anchor to urge thesecond wall toward the first wall without indicating the anchor forcebeing applied by the tensioning device. In such embodiments, the methodmay also include applying the desired anchor force to the second anchorwith the tensioning device in a second mode of operation, where thesecond mode of operation allows the tensioning device to provide theindication of the anchor force applied to the second anchor by thetensioning device. In such embodiments, the method may further includeactuating a mode button or level mechanism of a main body of thetensioning device to switch the tensioning device from the first mode ofoperation to the second mode of operation.

In any of the embodiments, the applied anchor force may include aVentricular Contractile Force (VCF) and an additional force of betweenabout 2N and about 6N. Alternatively, the applied anchor force mayinclude a Ventricular Contractile Force (VCF) and an additional force ofbetween about 3N and about 4N.

According to another embodiment, a system for securing heart anchors ofa heart implant device is provided. The system may include a tensionmember having a first end and a second end, a first anchor coupled withthe tension member at the first end, and a second anchor slidablycouplable with the tension member. The first anchor may be configuredfor anchoring engagement with a first wall of the heart. The secondanchor may have a variable force mode that allows the second anchor toaxially slide proximally and distally along the tension member and a setforce mode that inhibits proximal movement of the second anchor alongthe tension member. The second anchor may be configured for anchoringengagement with a second wall of the heart. The system may also includea tensioning device that is configured to: engage the second anchor toapply an anchor force between the tension member and the second anchor,provide an indication of the anchor force being applied to the secondanchor by the tensioning device, and switch the second anchor from thevariable force mode to the set force mode and vice versa.

In some embodiments, the tensioning device may be operable in a firstmode that allows the tensioning device to engage the second anchor andapply the anchor force without providing an indication of the anchorforce, and operable in a second mode that allows the tensioning deviceto provide the indication of the anchor force applied to the secondanchor by the tensioning device.

In some embodiments, the system may additionally include a tissuepenetrating device that has an elongate shaft and a lumen extendingbetween a proximal end and a distal end of the elongate shaft. A firstneedle may be disposed within the lumen of the elongate shaft and may beextendable therefrom between a first configuration, in which the firstneedle is substantially aligned with an axis of the lumen, and a secondconfiguration, in which the first needle curves away from the axis ofthe lumen. A second needle may be disposed within a lumen of the firstneedle and extendable therefrom to penetrate the first wall or secondwall of the heart.

In some embodiments, the system may additionally include a cannula ortrocar through which an elongate shaft of the tensioning device isinserted to engage a distal end of the tensioning device with the secondanchor while a main body of the tensioning device remains positionedoutside the body. In such embodiments, the elongate shaft may include alumen through which the tension member is insertable to allow thetensioning device to be advanced over the tension member through thecannula or trocar. In some embodiments, the tensioning device mayinclude indicia that indicates the force being applied to the secondanchor by the tensioning device.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention is described in conjunction with the appendedfigures:

FIG. 1 illustrates a front and side view of a tissue penetrating device.

FIG. 2 illustrates a perspective view of the tissue penetrating deviceof FIG. 1.

FIGS. 3A-3C illustrate the tissue penetrating device of FIG. 1 with aninner and outer needle retracted within an elongate shaft.

FIGS. 4A-4C illustrate the tissue penetrating device of FIG. 1 with theinner needle extending from the elongate shaft.

FIGS. 5A-5C illustrate the tissue penetrating device of FIG. 1 with theouter needle extending from the elongate shaft.

FIGS. 6A-6C illustrate the tissue penetrating device of FIG. 1 with theouter needle extending from the elongate shaft and with the inner needleextending from the outer needle.

FIG. 7A illustrates a reconstructed left ventricle using a series ofimplanted anchors so as to mitigate the deleterious effects ofcongestive heart failure.

FIG. 7B illustrates a cross-sectional view of the heart of FIG. 7A,showing a reduction in the size of the left ventricle effected by one ofthe implants.

FIGS. 7C and 7D illustrate minimally invasive access to and endoscopicimaging of a pericardium of the heart.

FIG. 7E illustrates joining of a femoral access tool path through theright atrium and an endoscopic trans-epicardial access tool path bysnaring a guidewire within the right ventricle of the heart.

FIG. 8A illustrates a trocar or shaft positioned adjacent an externalwall of a heart in a treatment for congestive heart failure.

FIG. 8B illustrates an inner needle penetrating through the externalwall of the heart in the congestive heart failure treatment.

FIG. 8C illustrates an outer needle being positioned adjacent the septalwall of the heart in the congestive heart failure treatment.

FIG. 8D illustrates the inner needle penetrating through the septal wallof the heart in the congestive heart failure treatment.

FIG. 8E illustrates a guidewire being inserted into the right ventricalof the heart so as to be snared by a snare device and join paths of theguidewire and snare device in the congestive heart failure treatment.

FIG. 8F illustrates the joined paths of the guidewire and snare devicein the congestive heart failure treatment.

FIG. 8G illustrates a septal anchor positioned adjacent the septal walland a tension member extending through the septal wall and external wallin the congestive heart failure treatment.

FIG. 8H illustrates an epicardial anchor application device being usedto slide an epicardial anchor distally along the tension member andadjacent the external wall of the heart in the congestive heart failuretreatment.

FIG. 8I illustrates the setpal anchor and epicardial anchor being usedto reconfigure the shape of the heart and the volume of the leftventricle in the congestive heart failure treatment.

FIG. 9A illustrates a cross section view of a tissue penetrating devicehaving a spring actuated triggering mechanism according to anembodiment.

FIGS. 9B-E illustrate enlarge cross sectional views of the tissuepenetrating device of FIG. 9A.

FIGS. 10A-E illustrate an embodiment of an epicardial anchor applicationdevice.

FIGS. 11A-D illustrate an embodiment of an exemplary epicardial anchor.

FIG. 12 illustrates a method for securing heart anchors of a heartimplant device.

In the appended figures, similar components and/or features may have thesame numerical reference label. Further, various components of the sametype may be distinguished by following the reference label by a letterthat distinguishes among the similar components and/or features. If onlythe first numerical reference label is used in the specification, thedescription is applicable to any one of the similar components and/orfeatures having the same first numerical reference label irrespective ofthe letter suffix.

DETAILED DESCRIPTION OF THE INVENTION

The present invention generally provides improved medical devices,systems, and methods. Exemplary embodiments of the devices are describedfor use in reducing the distance between a region along the septum and aregion of an external wall of the left ventricle of a heart in a less orminimally invasive manner. Hence, embodiments of the tools and methodsdescribed herein may find specific use in the treatment of congestiveheart failure and other progressive heart diseases by reconfiguringabnormal heart geometry that may be contributing to heart dysfunction.For congestive heart failure therapies, perforating both the exteriorwall and the septum from an epicardial approach can provide significantbenefits in control over the locations of implant deployments, therebyeffectively enhancing the resulting reshaping of the ventricularchamber. Despite this largely epicardial approach, there are surprisingbenefits to guiding deployment of the implant from along both theepicardial access path and another access path into and via an accesspath through the right ventricle. This additional right atrial accesspath into the heart may be via the superior vena cava, the inferior venacava, the right atrial appendage, or the like, and the pathways may bejoined together by coupling of a snare to a guidewire or the like withinthe right ventricle, the right atrium, the right pulmonary artery, orthe like. While a variety of tools will be described herein forproviding access pathways, for joining pathways together within theheart, for deploying implants, for maintaining hemostasis, and the like,it should be recognized that alternative embodiments may employadditional or alternative structures, some of which may beoff-the-shelf, and some of which may be new structures configuredparticularly for use in the advantageous therapies described herein.

Joining pathways may be accomplished by using a guidewire and snaredevice. To join the pathways, the guidewire is often inserted throughthe external wall and septal wall of the heart. The external wall and/orseptal wall are often composed of relatively tough scar tissue, whichmakes insertion of the guidewire through these walls relativelychallenging. For example, relatively thin and long needles (e.g., 17Gauge (0.058″)) are often used to penetrate the scar tissue of theexternal and/or septal walls. The needles need to be relatively long toallow a physician to position the needle through a small incision,through the external wall, and through the septal wall. These thin andlong needles often bend or buckle as they are pressed firmly against thetough scar tissue, which complicates the wall penetrating processes.Further, the needle insertion points for the external wall and septalwall are typically not aligned relatively to one another. Rather, theinsertion points are often angled or offset from one another by somedegree. As such, straight needles are often relatively difficult to workwith in penetrating both the external wall and the septal wall.

The tissue penetrating device described herein is able to easilypenetrate tough scar tissue while compensating for the offset insertionpoints of the external wall and septal wall. This is accomplished byproviding a needle and sleeve combination, or a pair of needles, thatare coaxially aligned and that slide relative to one another. The needleor inner needle (hereinafter the inner needle) is a small sharp needlethat is used to initially penetrate the tough scare tissue of theexternal wall and septal wall. In initially penetrating the scar tissue,the sleeve or outer needle (hereinafter outer needle) is positionedadjacent the scar tissue and over the inner needle. In this manner theouter needle supports the inner needle and prevents or reduces bendingand/or buckling of the inner needle. After the inner needle penetratesthe scar tissue, the outer needle may then be advanced over the innerneedle and through the tough scar tissue of the external wall or septalwall.

Further, the outer needle is made of a flexible shape-memory material,such as nitinol, that is able to bend or flex as the outer needle isadvanced distally of a distal end of an elongate shaft. As such, afterthe outer needle is inserted through the external wall, the outer needlemay be advanced distally of the external wall, which causes the outerneedle to bend toward the insertion point of the septal wall, which maybe offset from the insertion point of the external wall. The outerneedle may be configured to have any desired degree of bend so as toaccommodate patients of various shape and size. The inner needle maylikewise be made of a flexible material, such as nitinol, to allow theinner needle to be advanced within a lumen of the outer needle withoutaltering the bent or flexed configuration of the outer needle. The outerand inner needle may be positioned adjacent a desired insertion point onthe septal wall and the inner needle may be advanced distally of theouter needle and through the septal wall. A guidewire may then beinserted through a lumen of the inner needle, through the external walland septal wall, and into a chamber of the heart for snaring and joininginsertion paths as described herein.

For convenience in describing the embodiments herein, the sleeve orouter component is referred to herein as an outer needle. It should berealized, however, that the outer component is not limited to needlesand that the outer component may be a sleeve, catheter, elongate shaft,or tube that is configured to track over the inner needle and bend orflex as described herein. In some embodiments, however, the outercomponent may be a needle that is capable to some degree of insertionthrough tissue with or without the inner needle.

In some embodiments, an epicardial anchor application tool or device maybe used to facilitate the engagement of the setpal and external walls ofthe heart and to lock an epicardial anchor about a tether or tensionmember with the setpal and external walls in engagement. The epicardialanchor application tool or device may include a force gauge or tensionindicating mechanism/member that provides an indication to a user of aforce that is being applied to the epicardial anchor during engagementof the septal and external walls. The force gauge allows an appropriateamount of force to be applied to the anchor to engage the heart wallswithout risking damage to the heart walls from over-tensioned heartanchors. In this manner, proper healing of the heart tissue may beencouraged or promoted.

The epicardial anchor application tool or device may be inserted over atether and into contact with the epicardial anchor. The epicardialanchor application tool or device may be configured to move theepicardial anchor proximally and distally along the tether and intoengagement with the external wall. As the epicardial anchor applicationtool or device is moving the epicardial anchor distally along thetether, the epicardial anchor application tool or device may be operatedin a first mode wherein an indication of the force exerted on theepicardial anchor is not provided to the user. When the septal andexternal walls contact one another, the epicardial anchor applicationtool or device may be switched to a second mode wherein an indication ofthe force exerted on the epicardial anchor is provided to the user. Theuser may then use force application feedback provided by the epicardialanchor application tool or device to appropriately tension theepicardial anchor, the tether, and a septal anchor to maintain thesepatal and external walls in engagement at a level that promoteshealing.

The epicardial anchor application tool or device may also be used tolock the epicardial anchor in position relative to the tether and inengagement with the external wall. The epicardial anchor applicationtool or device may further unlock the epicardial anchor to allow forremoval of the anchor and/or for the force applied by the anchor on theheart wall to be adjusted. To enable locking and unlocking of theepicardial anchor, the epicardial anchor application tool or device mayinclude a mechanism that engages with and reconfigures the epicardialanchor between a variable force mode in which the anchor is able toslide distally and proximally along the tether, and a set force modethat restricts proximal movement of the anchor along the tether. Havinggenerally described some embodiments, additional feature of theembodiments will be recognized with reference to the figures describedbelow.

Referring now to FIG. 1, illustrated is a tissue penetrating device 100that may be used to penetrate various tissue of the patient, such as anexternal wall and/or septal wall of a heart. Tissue penetrating device100 includes a tool body 102 that may be grasped by a physician during atissue penetrating operation. Attached to body 102 is a pair of fingerguides 104 through which the physician may insert his or her fingers. Asecond finger guide 106, or trigger mechanism, is also slidably coupledwith body 102. Finger guide 106 is able to slide axially along body 102via track 116 to deploy and retract an outer needle 120 relative to anelongate shaft 110. A second trigger mechanism 108 is also slidablycoupled with body 102. Second trigger mechanism 108 is axially movablealong body 102 via track 116 to deploy and retract an inner needle (122of FIG. 2 and the like) relative to elongate shaft 110 and outer needle120.

Second trigger mechanism 108 is operable independently of first triggermechanism 106 so that the inner needle 122 and outer needle 120 areindependently deployable and retractable to at least some degreerelative to one another. Body 102 also includes one or more ports, 112and 114, through which a guidewire, tether or tension member, and thelike may be inserted, or which may function to fluidly couple a pressuresensing fluid pathway with an external pressure monitoring or measuringdevice (not shown).

Outer needle 120 and inner needle 122 are disposed within a lumen ofelongate shaft 110 and slidable relative thereto so as to be extendablefrom the lumen of elongate shaft 110 and retractable within the lumen.Further, outer needle 120 and the inner needle 122 are coaxially alignedand slidable relative to one another. Outer needle 120 is disposed overinner needle 122 with inner needle 122 being slidably disposed within alumen of outer needle 120. Inner needle 122 is extendable distallybeyond a distal end of outer needle 120 and retractable within the lumenof outer needle 120.

FIG. 2 shows a perspective view of another embodiment of tissuepenetrating device 100. FIG. 2 illustrates the finger guides 104positioned at a proximal end of body 102. FIG. 2 further illustrates thesecond finger guide 106 slid proximally away from finger guides 104,which typically results in outer needle 120 and inner needle 122 beingretracted within the lumen of elongate shaft 110. For illustrativepurposes, however, outer needle 120 is shown being extended distally ofelongate shaft 110 even though the second finger guide 106 is slidproximally away from finger guides 104. FIG. 2 additionally shows thatthe second trigger mechanism 108 may be coupled with a shaft or tubethat is slidable within body 102 and/or within a shaft or tube of firsttrigger mechanism 106. The shaft or tube of the second trigger mechanism108 and/or the shaft or tube of the first trigger mechanism 106 mayinclude locking components 117 that help maintain the position of thesecond trigger mechanism's shaft or tube and/or first triggermechanism's shaft or tube relative to one another and/or to body 102.Further, in some embodiments, the locking component 117 may helpmaintain a positional relationship between the inner needle 122 and theouter needle 120. For example, as the outer needle 120 is advanceddistally of the distal end of elongate shaft 110, the inner needle 122may remain in position until the distal tips of both the inner needle122 and the outer needle 120 substantially align. Afterward, the lockingcomponent 117 may lock the first and second trigger mechanisms, 106 and108, together so that further advancement of the outer needle 120 causesthe inner needle 122 to also advance.

FIG. 2 additionally shows that an outer sleeve 130 may be slidablydisposed over elongate shaft 110. Outer sleeve 130 may include a lockingmechanism 132 that is couplable with a tissue anchoring device (notshown) that is positioned adjacent and/or removably coupled with tissueor an organ of the body (e.g., the heart) through which the inner needle122 and/or outer needle 120 are to be inserted. An exemplary embodimentof a tissue anchoring device is further described in U.S. patentapplication Ser. No. 14/471,973 filed Aug. 28, 2014, entitled “CardiacTissue Anchoring Devices, Methods, and Systems for Treatment ofCongestive Heart Failure and Other Conditions,” the entire disclosure ofwhich is hereby incorporated by reference, for all purposes, as if fullyset forth herein.

As shown in FIGS. 1 and 2, when axially extended from elongate shaft110, outer needle 120 may bend, flex, or curve away from an axis ofelongate shaft 110's lumen. As described herein, outer needle 120 may bemade of a flexible shape-memory material, such as nitinol, that is ableto bend or curve by a radius R as the outer needle 120 is advanceddistally of a distal end of an elongate shaft 110. The flexible materialof outer needle 120 also allows the outer needle to straighten when theouter needle 120 is retracted within elongate shaft 110's lumen. Whenretracted within elongate shaft 110's lumen, outer needle 120 issubstantially aligned with an axis of elongate shaft 110's lumen. Theradius of curvature R may be selected such that when the outer needle120 is advanced distally from a distal end of elongate shaft 110, adistal end of outer needle 120 is curved or bent away from the axis ofthe elongate shaft 110's lumen by between 45 and 210°, and more commonlyby about 80 and 120°. In one embodiment, the radius of curvature R maybe between about 10 and 38 mm. This radius of curvature range of outerneedle 120 is found to be sufficient for the majority of patients.

In some embodiments, the radius of curvature R and/or degree of bend ofthe outer needle 120 may be dynamically adjusted. For example, when theouter needle 120 is made of nitinol, the radius of curvature R and/orbend of the outer needle 120 may be adjusted by varying the temperatureof the needle. The temperature of the nitinol needle may be varied whilethe needle is within or external to the patient's body and may be variedautomatically (e.g., the patient's body temperature may vary theneedle's temperature) or in a controlled manner (e.g., via resistiveheating of the needle and the like). This variation and control of theouter needle 120's shape may allow a physician to adjust the needle tofit or conform to a specific patient's geometry and/or allow a singleneedle to be used multiple times, such as to place multiple anchors whentreating congestive heart failure.

The inner needle 122 is also made of a flexible material, such asnitinol, that allows the inner needle 122 to curve, flex, or bend byradius R as the inner needle 122 is advanced simultaneously with outerneedle 120, or slid within the lumen of outer needle 120. Theflexibility of the inner needle 122 prevents the inner needle 122 fromstraightening or otherwise affecting the radius of curvature R of outerneedle 120. Stated differently, because the inner needle 122 is alsomade of a flexible material, the inner needle 122 may be advancedsimultaneously with outer needle 120, or slid within the lumen of outerneedle 120, and bent, flexed, or curved by outer needle 120 as outerneedle 120 is advanced distally from elongate shaft 110. The flexibilityof inner needle 122 also allows the inner needle 120 to be straightenedwhen the inner needle 122 and/or outer needle 120 are retracted withinelongate shaft 110's lumen. When retracted within the lumen of elongateshaft 110, inner needle 122 is substantially aligned with the axis ofthe elongate shaft 110's lumen.

The dual needle arrangement of the tissue penetrating device 100stabilizes the inner needle 122 as the inner needle 122 is insertedthrough tissue of the patient. Since both the inner needle 122 and theouter needle 120, which is coaxially aligned with and positioned overinner needle 122, are positioned adjacent the patient's tissue that isto be penetrated with inner needle 122, the outer needle 120 provides arelatively rigid sheath that reinforces the inner needle 122 as theinner needle is penetrated through the patient's tissue. Thisconfiguration prevents or reduces buckling or bending of the innerneedle 122 as the inner needle 122 is inserted through the patient'stissue. This configuration also allows the penetrating force of theinner needle 122 to be concentrated at a distal tip of the inner needle122, thereby enabling the inner needle 122 to easily puncture throughtough scar tissue or other tissue, which may otherwise cause bending orbuckling of the inner needle 122.

Although not shown in FIGS. 1 and 2, in some embodiments the firsttrigger mechanism 106 and/or second trigger mechanism 108 may bespring-loaded such that actuation of the first trigger mechanism 106and/or second trigger mechanism 108 causes a spring to rapidly fire ordeploy the outer needle 120 and/or inner needle 122 across the tissue ofthe patient (see FIGS. 9A-E). Spring-loading the first trigger mechanism106 and/or second trigger mechanism 108 may allow the inner needle 122and/or outer needle 120 to easily penetrate relatively tough scar tissueor other tissue. Spring-loading of the trigger mechanisms, however, istypically not necessary and in fact may not be desired, since thesupport provided by the outer needle 120 allows the inner needle 122 toeasily penetrate tough scar tissue and other tissue. In otherembodiments, the first and/or second trigger mechanism may include apneumatic mechanism that causes the inner needle 122 and/or outer needle120 to be advanced via pressurized fluids.

In some embodiments, inner needle 122 may be an approximately a 21 Gauge(0.033 in) needle while outer needle 120 is a slightly larger needle,such as a 17.5 Gauge (0.054 in) needle and the like. The dimensions ofthe needles may be adjusted based on need, patient size, application orprocedure, or otherwise as desired. In some embodiments, an outerdiameter of elongate shaft 110 and/or outer sleeve 130 is smaller thanabout 5 mm or 7.5 mm to allow the elongate shaft 110 and/or outer sleeve130 to be inserted through a 5 mm or 7.5 mm trocar that is positionedthrough a relatively small incision in the patient's skin.

In some embodiments, the distal end of elongate shaft 110 may include ajoint member (see 126 of FIG. 3C and the like) that is couplable with atissue anchoring or attachment device, such as those described in the'973 incorporated herein, that is positioned on or adjacent tissue to bepenetrated with inner needle 122. The joint member 126 may allow theelongate shaft 110 and body 102 to be aligned relative to the tissueanchoring device by some degree, such as up to about 10 and 30°. Thisallows the distal tip of elongate shaft 110 to be positioned adjacentthe tissue to be penetrated with inner needle 122 and for the tissuepenetrating device 100 to be offset so that the inner needle 122 willpenetrate the tissue at a desired angle and/or so that the outer needle120 will be positioned adjacent a desired insertion point of additionaltissue after the outer needle 120 is advanced from elongate shaft 110and flexed or curved by radius R. The joint member 126 allows the outerneedle 120 and inner needle 120 to be steered posterior or anterior tothe heart or so some feature of the heart. For example, the alignment ofthe elongate shaft 110 relative to the tissue anchoring device and heartmay be adjusted so that a tip of the outer needle 120 (i.e., in a bentor straight configuration) and/or the inner needle 122 may be positionedcloser to a heart's apex, base, valve, septal or exterior wall, and thelike as desired. This effectively allows the outer and/or inner needle'stip to be steered within or relative to a patient's heart or othertissue as needed or desired, which facilitates in precise placementand/or penetration of the needles relative to the tissue. Steering ofthe outer needle 120 and/or inner needle 122 may be further facilitatedvia the use of an imaging device (e.g., a thoracoscope, fluoroscope, andthe like).

In one embodiment, when the tissue penetrating device 100 is used fortreating congestive heart failure, the tissue penetrating device 100 maybe aligned so that the distal tip of elongate shaft 110 and/or outerneedle 120 is positioned toward an apex of the heart, toward a base ofthe heart, and/or toward any other desired feature of the heart. In someembodiments, the distal tip of outer needle 120 and/or inner needle 122may be radiopaque so that the distal tip is easily identifiable via animaging device (e.g., a thoracoscope, fluoroscope, and the like).Further, the locking mechanism 132 of outer sleeve 130 may couple theelongate shaft 110 with the tissue anchoring device and the joint member126 may allow some degree of movement off-axis of the elongate shaft 110relative to the tissue anchoring device as further described in the '973incorporated herein.

In still other embodiments, the distal tip of the outer needle 120and/or inner needle 122 may include a fluid pathway that allows aphysician to monitor or measure pressure within the patient's body, suchas within a chamber of the heart. Monitoring or measuring pressure mayallow the location of the tip of the needle within the patient's body tobe determined. In other embodiments, the distal tip of the needle 120and/or inner needle 122 may include a pressure transducer that allows apressure within the patient to be measured or determined as either orboth needles are inserted through tissue of the patient and/or withinone or more chambers within the body. For ease in describing theembodiments herein, the needle's pressure sensing fluid pathway,pressure transducer, and the like, will be referred to hereinafter as apressure sensing element.

In one embodiment, when the tissue penetrating device 100 is used fortreating congestive heart failure, the pressure sensing element (e.g.,fluid pathway and the like) may be used to determine when the innerneedle 122 and/or outer needle 120 have penetrated through the externalwall of the heart, when the inner needle 122 and/or outer needle 120 arepositioned within a chamber of the heart, when the inner needle 122and/or outer needle 120 are positioned adjacent a septal wall of theheart, and/or when the inner needle 122 has penetrated through theseptal wall and is positioned within the right ventricle of the heart.For example, the pressure sensing element may be used to measure ormonitor left ventricle heart pressure, right ventricle heart pressure,and/or a damped pressure that corresponds to when the needle is imbeddedwithin the wall of the heart (e.g., septum wall). The pressure sensingelement may also be used to determine when the inner needle 122 and/orouter needle 120 are positioned adjacent scar tissue or contractiletissue of the heart to enable the physician to determine if the innerneedle 122 and/or outer needle are adjacent a desired insertion point.In a specific embodiment, the inner needle 122 includes the pressuresensing element and the inner needle is used to sense pressure withinthe heart and/or elsewhere within the patient's body.

Referring now to FIGS. 3A-6B, illustrated is an embodiment of operatinga tissue penetrating device 100. Specifically, FIGS. 3A-3C illustratethe first trigger mechanism 106 and the second trigger mechanism 108being positioned in a proximal position relative to body 102 such thatthe inner needle 122 and outer needle 120 are fully retracted anddisposed within the lumen of elongate shaft 110. In some embodiments,locking mechanism 132 may comprise threads that may be threaded with acorresponding aperture of a tissue anchoring device as described in the'973 application incorporated herein. FIG. 3B illustrates an enlargedperspective view of body 102 and several components of the device 100and illustrates that body 102 may include indicia that facilitates ininforming a physician of the deployment of the outer needle 120 and/orinner needle 122.

With the inner needle 122 and outer needle 120 fully retracted anddisposed within the lumen of elongate shaft 110, the distal tip ofelongate shaft 110 may be positioned adjacent the patient's tissue to bepenetrated with inner needle 122, and/or the distal tip of elongateshaft 110 may be coupled with a tissue anchoring device that ispositioned adjacent the patient's tissue. After the distal tip ofelongate shaft 110 is positioned adjacent the patient's tissue, secondtrigger mechanism 108 may be slid distally along body 102 to axiallyadvance inner needle 122 from the lumen of elongate shaft 110 and outerneedle 120. The second trigger mechanism 108 may be slid distally alongbody 102 by placing a finger (e.g., a forefinger) within the firsttrigger mechanism 106 and by pressing on the second trigger mechanism108 with another finger (e.g., a thumb). FIGS. 4A-4C illustrate theinner needle 122 extended from elongate shaft 110 after the secondtrigger mechanism 108 is slid distally along body 102. As shown in FIG.4A, second trigger mechanism 108 is positioned directly adjacent thefirst trigger mechanism 106 after second trigger mechanism 108 is sliddistally along body 102.

Advancing the inner needle 122 from elongate shaft 110 as shown in FIG.4C causes the inner needle 122 to penetrate through tissue positionedadjacent the distal tip of elongate shaft 110. In this configuration,first trigger mechanism 106 may be slid distally along body 102 to causethe outer needle 120 to slide within the lumen of elongate shaft 110 andadvance distally from elongate shaft 110. Sliding the first triggermechanism 106 distally along body 102 may be performed by placing afinger or fingers within finger guides 104 and by pressing on firsttrigger mechanism 106 with another finger. FIGS. 5A-5C illustrate theouter needle 120 extending from the distal end of elongate shaft 110after the first trigger mechanism 106 is slid distally along body 102.

As shown, the inner needle 122 may be retracted within an outer needle120 as the first trigger mechanism 106 is slid distally along body 102.Retraction of the inner needle 122 may occur automatically as the firsttrigger mechanism 106 is slid along body 102. For example, the innerneedle 122 may remain in position as the outer needle 120 is advanceduntil the distal tips of the inner needle and outer needle substantiallyalign. Afterwards, advancement of the outer needle 120 may cause theinner needle 122 to also advance so that the distal tips of the innerneedle 122 and outer needle 120 remain substantially aligned. In otherembodiments, the retraction of inner needle 122 may be a manual processthat is performed by a physician, such as by holding the second triggermechanism 108 in place as first trigger mechanism 106 is slid distallyalong body 102, or by sliding second trigger mechanism 108 proximallyalong body 102. As shown in FIG. 5B and as described herein, outerneedle 122 bends or curves away from an axis of the lumen of elongateshaft 110 as the outer needle 120 is advanced distally away from thedistal end of elongate shaft 110. The distal end of outer needle 120 maybe advanced away from the distal end of elongate shaft 110 until thedistal end of outer needle 120 (and the distal end of inner needle 122)is positioned adjacent tissue to be penetrated with inner needle 122. Asdescribed herein, the outer needle 120 is made of a flexibleshape-memory material and has a preconfigured curved that may beconfigured or selected to fit or accommodate the heart geometry of aspecific patient.

After the distal end of the outer needle 120, and inner needle 122, ispositioned adjacent tissue to be penetrated with inner needle 122, thesecond trigger mechanism 108 may be slid distally along body 102 toextend inner needle 122 beyond the distal end of outer needle 120 andthereby penetrate the patient's tissue. FIGS. 6A-6C illustrate thesecond trigger mechanism 108 being slid distally along body 102 toextend inner needle 122 so as to penetrate tissue of the patient. FIG.6A also illustrates a track 116 within which the first trigger mechanism106 and/or second trigger mechanism 108 may slide.

Referring now to FIGS. 7A-8I, a procedure for treating congestive heartfailure using the tissue penetrating device 100 is illustrated.Specifically, FIGS. 7A and 7B illustrate a series of implants 10implanted in a heart H so as to decrease a cross-section of a leftventricle LV. Each implant 10 generally includes a first anchor 12, asecond anchor 14, and a tension member 16 coupling the anchors together.Tension in the tension member 16 is transferred from the anchors, 12 and14, to the septum S and the external wall EW bordering the leftventricle LV so as to bring these structures into engagement, therebyeffectively excluding a region of scar tissue ST from the leftventricle. In many embodiments described herein, implant 10 will bedeployed by penetrating the external wall EW and septum S via apericardium P of the heart H, and also by accessing a right ventricle RVvia a right atrium. Anchors deployed within a right ventricle and/or inengagement with the septum S may sometimes be referred to herein asseptal anchors, while anchors deployed along the external wall EW of theleft ventricle LV may be referred to as epicardial anchors.

Referring now to FIGS. 7C and 7D an MRI image I taken along viewingplane VP schematically illustrates use of a thoracoscope or fluoroscope20 to provide a field of view encompassing a region of the pericardiumof the heart, with the region including a target site for deployment ofone or more epicardial anchors and/or septal anchors of the implantsystem.

Referring now to FIG. 7E, joining of an access path through the rightatrium to an access path through the pericardium and epicardium bysnaring of a guidewire within the right ventricle underthoracoscopic/fluoroscopic guidance 20 is schematically illustrated. Theright atrial access path may extend into the arterial vasculature viathe femoral artery FA and inferior vena cava IVC, via the jugular arteryJA via the superior vena cava, or the like. As can be understood withreference to FIG. 8A, a selected location for perforation of theexternal wall EW can be identified using an image fromthoracoscope/fluoroscope 20, optionally in combination with an imagefrom another imaging modality (such as a prior or contemporaneous imagefrom an ultrasound imaging system, an MRI imaging system, an X-ray orfluoroscopic imaging system, a CT imaging system, and the like). Inexemplary embodiments, a shaft 430 of an access tool having a workinglumen therethrough is advanced through the epicardium of the beatingheart so that a distal end of the shaft 430 is positioned adjacent theexternal wall EW of the heart. Shaft 430 may comprise a trocar and mayhave a proximal hemostasis valve at its proximal end so as to inhibitbloodflow through the lumen and facilitate insertion and/or removal ofelongate shaft 110 or outer sleeve 130 of tissue penetrating device 100.

A catheter 404 is inserted into the arterial vasculature via the jugularartery JA and tricuspid valve; or in other embodiments, via the femoralartery FA and inferior vena cava IVC, via the via the superior venacava, and the like. A snare device 402, such as a wire hoop or wirebasket, is positioned against the septum S at or adjacent an insertionpoint for inner needle 122. Snare device 402 may be positioned againstseptum S by using an off-the-shelf steerable catheter 404. The snaredevice 402 may provide a target for inner needle 122. Snare device 402may be easily visible via fluoroscopy 20 and provide a reference pointfor steering the inner needle 122 and/or outer needle 120. As describedherein, the distal tip of inner needle 122 and/or outer needle 120 maybe radiopaque so that the distal tip of either or both needles is easilyvisible with a fluoroscope 20.

Shaft 430 may be positioned adjacent the external wall EW by insertingthe shaft 430 through an incision between ribs of the patient, such asbetween the fourth and fifth intercostal space. Although not shown inthe figures, in some embodiments the tissue anchoring device may beinserted through a subxiphoid incision and positioned adjacent theexternal wall EW. The subxiphoid incision may be relatively small, suchas a two or three finger incision. The tissue anchoring device may becoupled with the external wall EW and a distal end of the shaft 430, ora distal end of elongate shaft 110, may be coupled with the tissueanchoring device to attach and/or stabilize the shaft 430 and/orelongate shaft 110 adjacent the external wall EW. Thethoracoscope/fluoroscope 20 may also be inserted through the subxiphoidincision.

As shown in FIG. 8B, with the shaft 430 positioned adjacent externalwall EW, the second trigger mechanism 108 may be actuated so as toadvance inner needle 122 from the lumen of elongate shaft 110 and thelumen of outer needle 120 in order to penetrate the external wall EW. Apressure sensing element of inner needle 122 (e.g., fluid pathway,pressure transducer, and the like) may be used to determine that theinner needle 122 is positioned adjacent the external wall EW and/orinserted through the external wall EW and into the left ventricle LV. Asshown in FIG. 8C, after the inner needle 122 is inserted through theexternal wall EW, the first trigger mechanism 106 may be actuated toextend the outer needle 120 distally of elongate shaft 110 and throughexternal wall EW. The outer needle 120, and inner needle 122, may beadvanced distally of elongate shaft 110 so that the outer needle 120curves or bends away from an axis of the lumen of elongate shaft 110 andtoward septum S. The inner needle 122 may be retracted within an outerneedle 120 as the outer needle 120 is advanced toward septum S so as toprevent the inner needle 122 from penetrating other tissue of heart H.The outer needle 120 may be advanced until a distal end of outer needle120 is positioned adjacent septum S. The pressure sensing element ofinner needle 122 and/or of outer needle 120 may be used to determinethat the distal tip of outer needle 120 is positioned adjacent septum S.

The snare device 402 and radiopaque distal tip of outer needle 120and/or inner needle 122 may also be imaged via fluoroscope 20 todetermine that the distal tip of outer needle 120 is near snare device402. As described herein, as the outer needle 120 curves or bends as itis being distally advanced, the inner needle 122 is also forced to curveor bend along with outer needle 120. As shown in FIG. 8D, when the outerneedle 120 and inner needle 122 are positioned adjacent septum S, thesecond trigger mechanism 108 may be actuated so as to advance innerneedle 122 distally of outer needle 120 and penetrate the septal wall S.The inner needle 122 is inserted through septum S and into rightventricle RV so that the distal end of inner needle 122 is disposedwithin snare 402. As shown in FIG. 8D, the guidewire GW is then insertedthrough a lumen of inner needle 122 and into right ventricle RV. Thesnare device 402 may then be refracted within catheter 404 so that thesnare device 402 snares the distal tip of inner needle 122 and/orguidewire GW. With the distal tip of inner needle 122 snared by snaredevice 402, the inner needle 122 and outer needle 120 may be retractedwithin elongate shaft 110 so that the guidewire GW remains snared withinsnare device 402.

The inner needle 122, outer needle 120, and elongate shaft 110 may thenbe removed from the patient's body and the guidewire GW may be pulledthrough catheter 404 or retracted through septum S and external wall EWto a position outside the patient's body. As shown in FIG. 8F, in thismanner, an insertion path of the guidewire GW and an insertion path ofthe catheter 404/snare device 402 may be joined so that the guidewireGW, or another wire, extends from a first point outside the patient'sbody, through the external wall EW, through the septum S, through thejugular artery JA or femoral artery FA, and outside the patient's bodyat a second and different point. With guidewire GW extending throughheart H and outside the patient's body as described above, a tensionmember or tether 412 may be coupled with the guidewire GW and insertedthrough the jugular artery JA, into the right ventricle RV, throughseptum S and external wall EW, and out of the patient's body. FIG. 8Fillustrates that the component inserted through heart H may representthe guidewire GW, the tension member 412, or both.

A septal anchor (i.e., 410 of FIGS. 8G-8I) is coupled with a distal endof tension member 412 so that as the tension member 412 is insertedthrough the jugular artery JA and through heart H, the septal anchor 410is brought into position adjacent septum S. Exemplary embodiments ofseptal anchors 410 and tension members 412 are described in U.S. patentapplication Ser. No. 13/632,104, filed Sep. 30, 2012 and entitled“Trans-Catheter Ventricular Reconstruction Structures, Methods, andSystems for Treatment of Congestive Heart Failure and Other Conditions”,the entire disclosure of which is incorporated herein by reference.

FIG. 8G illustrates the septal anchor 410 positioned adjacent septum Swithin right ventricle RV. Tension member 412 extends from septal anchor410 through septum S into left ventricle LV and through external wallEW. FIG. 8H illustrates that an epicardial anchor 414 is coupled withtension member 412 and slid distally along tension member 412 until theepicardial anchor 414 is positioned adjacent external wall EW. Anepicardial anchor application device 422 may be used to slide epicardialanchor 414 proximally and/or distally along tension member 412 toexternal wall EW. The epicardial anchor application device 422 may alsobe used to apply tension between septal anchor 410 and epicardial anchor414 to urge or bring the septum S and external wall EW together. Theepicardial anchor application device 422 may provide an indication ofthe force applied by the device 422 to the epicardial anchor 414. Thismay allow a user to determine when an appropriate force has been appliedto the anchor 414 to bring the septum S and external wall EW intoengagement without risking unnecessary damage to the heart and/oranchors—e.g., the anchors pulling or tearing through the heart tissue.

The epicardial anchor application device 422 may further be used to lockor secure the epicardial anchor 414 in place about tension member 412 toprevent the epicardial anchor 414 from moving proximally along tensionmember 412 and to keep the septum S and external wall EW in positionrelative to one another. The epicardial anchor application device 422may then be uncoupled from the epicardial anchor 414 and removed fromthe patient's body. An exemplary embodiment of an epicardial anchor 414is illustrated in FIGS. 11A-D and described in the '104 applicationincorporated herein. An exemplary embodiment of an epicardial anchorapplication device 422 is illustrated in FIGS. 10A-E and described ingreater detail herein below.

As shown in FIG. 8I, after the septal anchor 410 and epicardial anchor414 are tensioned so that the septum S and external wall EW are broughttogether, the tension member 412 proximal to epicardial anchor 414 maybe cut and discarded. The septal anchor 410 and epicardial anchor 414may be left in position relative to septum S and external wall EW withthe heart H reconfigured to reduce a volume of left ventricle LV andexclude scar tissue from the left ventricle LV. The above process may berepeated a plurality of times to position additional septal anchors 410and/or epicardial anchors 414 about the septum S and external wall EW.The anchors may be aligned about a desired contour of the heart, such asa contour defined by scar tissue and the like. In some embodiments, thecontour for placement of multiple anchors may be determined via an imageof the heart and insertion points for the anchors may be calculated ormeasured from the image. The insertion points may then be mapped ormarked on the heart, such as by using a template or pattern. In thismanner, the shape of heart H and the volume of left ventricle LV may bereconfigured as desired.

In some embodiments, deployment of multiple anchors about the septum Sand/or external wall EW may be accomplished using multiple access portsand trocars or cannulas, or multiple anchors may be deployed via thesame access port. For example, in some embodiments the tissuepenetrating device may be used to penetrate the external wall EW and/orseptum S in multiple locations via the same access port. The tissuepenetrating device is capable of delivering multiple penetrations via asingle access port due, in part, to the bending or curving of the outerand inner needle. Further, in some embodiments the tissue penetratingdevice may be inserted through various incisions to penetrate theheart's tissue and deliver heart anchors, such as through incisionsbetween ribs, subxiphoid incisions, and the like.

In another embodiment, the process illustrated in FIGS. 8A-I mayessentially occur in reverse. For example, the tissue penetrating devicemay be inserted into the arterial vasculature via the femoral artery FAand inferior vena cava IVC, via the jugular artery JA via the superiorvena cava, or the like. In such embodiments, the elongate shaft 110 maybe a catheter that is easily insertable and/or steerable through thepatient's arteries and into the arterial vasculature. The catheter(i.e., elongate shaft 110) may then be inserted into the right ventricleRV via the tricuspid valve and the distal tip of the catheter may bepositioned adjacent the septum S. The inner needle 122 may then beadvanced distally of the catheter to penetrate through the septum S. Theouter needle 120 may then be advanced through the septum S and advancedtoward the external wall EW. The outer needle 120 may bend, flex, orcurve as it is being advanced toward the external wall EW as describedherein.

A snare device 402 may be positioned adjacent the external wall EW andmay provide a target for placement of the distal tip of the outer needle120 relative to the external wall EW of the left ventricle LV. Thedistal tip of the outer needle 120 may be positioned adjacent theexternal wall EW at or near the target position defined by the snaredevice 402 and the inner needle 122 may be advanced distally of theouter needle 120's distal end to penetrate through the external wall EW.The inner needle 122, and/or a guidewire GW inserted through the innerneedle 122's lumen, may then be snared via snare device 402 so as tojoin a pathway of the guidewire GW and snare device 402 as describedherein. Placement of the septal anchors and/or epicardial anchors maythen be performed as described above.

In some embodiments, the snare device 402 may be inserted through theexternal wall EW and into the left ventricle LV and the outer needle 120may be advanced within the left ventricle LV toward the snare device402. The outer needle 122 may be advanced within the left ventricle LVuntil it is able to be snared by snare device 402, after which the outerneedle 120, inner needle 122, and/or guidewire GW may be snare to joinaccess paths and deploy septal and/or epicardial anchors as describedherein.

Referring now to FIGS. 9A-9E, illustrated is an embodiment of a tissuepenetrating device 900 having a spring actuated triggering mechanism.FIGS. 9B-9E illustrate enlarged cross section views of the device 900showing the various components in greater detail. Tissue penetratingdevice 900 may be actuated to rapidly fire or deploy an outer needleand/or inner needle across the tissue of the patient, such as across anexternal wall EW or septal wall S. Device 900 includes a straight needletrigger rod 901 that may be actuated by a physician to rapidly deploy aninner and/or outer needle, and more commonly only an inner needle.

Device 900 includes an outer housing 902. Device 900 further includes atrigger release sleeve 903 that may be rotated to release triggerrelease tabs 906 via a window 913 (FIG. 9C) and thereby actuate triggerrod 901. In one embodiment, device 900 may include 3 trigger releasetabs 906 and 3 windows 913. Device 900 additionally includes a triggerspring 904 that, upon actuation, causes trigger rod 901 to rapidly movedistally relative to the other components of device 900. Device 900 alsoincludes a spring 905 for trigger release sleeve 903. Device 900additionally includes a straight or inner needle 907 that is rapidlyfired or deployed upon actuation of trigger spring 904 and trigger rod901. Device 900 also includes a curved or outer needle 909 and twoneedle inserts 908 and 910. An elongated shaft or sheath 911 is coupledwith a distal end of insert 910 and includes a lumen within which outerneedle 909 and inner needle 907 are coaxially aligned and slidablydisposed. As shown in FIG. 9C, the trigger release tabs 906 may bepivotally coupled to housing 902 via a pivot pin 912 and may preventdistal movement of trigger rod 901 until released by rotating triggerrelease sleeve 903 and aligning trigger release tabs 906 withcorresponding windows 913.

Rotating trigger release sleeve 903 so as to align trigger release tabs906 with the corresponding windows 913 actuates trigger rod 901 andcauses the trigger rod 901 to spring forward via trigger spring 904until a distal end of trigger rod 901 contacts insert 908. The forwardspringing movement of trigger rod 901 causes inner needle 907 to rapidlydeploy relative to outer needle 909 and elongate shaft 911 and therebypenetrate tissue adjacent a distal end of the elongate shaft 911 and/orouter needle 909. The trigger rod 901, trigger spring 904, and triggerrelease sleeve 903 may be reset for subsequent firing.

FIGS. 10A-E illustrate an embodiment of an exemplary epicardial anchorapplication device 1000. FIG. 10A illustrates a perspective view of theepicardial anchor application device 1000. The epicardial anchorapplication device 1000 includes a main body 1002 and a secondary body1010 that is disposed within main body 1002 and axially moveablerelative thereto. A spring component (1030 of FIGS. 10D & 10E) isdisposed within the main body 1002 and engages a distal end of thesecondary body 1010 to allow the secondary body 1010 to move axiallywithin the main body 1002. The epicardial anchor application device 1000includes a switch, mode button, or locking mechanism 1050 that isactuatable by a user to lock and unlock the secondary body 1010 relativeto the main body 1002 as described herein.

The epicardial anchor application device 1000 further includes anelongate shaft 1020 that is coupled with and extends distally from thesecondary body 1010. The shaft 1020 is configured for insertion througha trocar or cannula positioned in an incision between ribs or elsewhereof a patient to allow a pair of hooks, 1022 and 1024, at the distal endof the elongate shaft 1020 to engage with an epicardial anchor (i.e.,1155 of FIGS. 11A-D). An engagement pin 1025 is positioned between thepair of hooks, 1022 and 1024, and is configured to engage a cam springmechanism of the epicardial anchor to lock and unlock the epicardialanchor about a tether or tension member as described hereinbelow.

In operation, the epicardial anchor application device 1000 is used tomove the epicardial anchor proximally and distally along the tether ortension member and into engagement with an external wall EW of theheart. The epicardial anchor application device 1000 may then be used toapply a force to the epicardial anchor to urge the external wall EWtoward and into engagement with the septum S. The pair of hooks, 1022and 1024, and engagement pin 1025 may then be used to lock theepicardial anchor about the tether or tension member with the externalwall EW and septum S in contact. The epicardial anchor applicationdevice 1000 is also configured to provide an indication of the forceapplied to the epicardial anchor as the external wall EW and septum Sare brought into engagement.

In some embodiments, the epicardial anchor application device 1000 maybe operated in a first mode and a second mode. In the first mode, thesecondary body 1010 may be locked relative to the main body 1002 toallow the epicardial anchor application device 1000 to move theepicardial anchor proximally and distally along the tether withoutproviding an indication of the force applied to the epicardial anchor.This may allow the external wall EW and septum S to be easily broughtinto contact since essentially the entire force applied by theepicardial anchor application device 1000 is transferred to theepicardial anchor. Stated differently, engaging the external wall EW andseptum S with the epicardial anchor application device 1000 positionedin the first or locked mode may be relatively easy since the forceapplied to the epicardial anchor application device 1000 and/or thebeating of the heart is not causing the secondary body 1010 to moveaxially within the main body 1002. When the external wall EW and septumS are brought into contact, the epicardial anchor application device1000 may be switched to the second mode that allows the secondary body1010 to move axially within the main body 1002 to provide an indicationof the force being applied to the epicardial anchor by the epicardialanchor application device 1000. In this manner a user may apply anappropriate amount of tension between the epicardial anchor and a septalanchor since the applied force is displayed, indicated, provided, orotherwise made available to a user.

The applied force may be sufficient to keep the external wall EW andseptum S in engagement with one another while minimizing or eliminatingunnecessary damage to the heart tissue. In some embodiments, the appliedforce may include a Ventricular Contractile Force (VCF), or a forcenecessary to overcome a beating of the heart, and an additional force ofbetween about 2N and about 6N. In another embodiment, the applied forcemay include a Ventricular Contractile Force (VCF) and an additionalforce of between about 3N and about 4N. These forces are sufficient toensure that the external wall EW and septum S remain engaged or incontact without damaging the tissue of the heart.

FIG. 10B illustrates a side profile view of the epicardial anchorapplication device 1000. FIG. 10B shows the secondary body 1010positioned within main body 1002 and shows the elongate shaft 1020extending distally from a distal end 1014 of the secondary body 1010.The lever mechanism 1012 is shown in a locked or engaged position inwhich the pair of hooks 1022 and 1024 would engage with an epicardialanchor and allow the anchor to move proximally and distally along atether as described below. To unlock or disengage the epicardial anchor,the lever mechanism 1012 may be rotated clockwise relative to thesecondary body 1010, which would result in the pair of hooks 1022 and1024 disengaging from the epicardial anchor, thereby locking the anchorabout the tether to restrict proximal movement of the anchor about thetether. FIG. 10B also shows the secondary body 1010 including indicia1018 that provides an indication of the anchor force applied to theepicardial anchor as the secondary body 1010 moves axially within themain body 1002. The indicia 1018 may include a plurality of concentricrings or markings positioned axially along the secondary body 1010 thateach indicate or display a number corresponding to an applied force(e.g., 1N, 2N, 3N, and the like).

FIG. 10C illustrates another side profile view of the epicardial anchorapplication device 1000 with the device rotated approximately 90 degreesabout a central axis. FIG. 10C illustrates many of the components ofepicardial anchor application device 1000 previously described andfurther illustrates the locking mechanism or mode button 1050 in greaterdetail. Specifically, locking mechanism 1050 includes a proximal endhaving a boss or shaft 1054 that extends into an aperture (not shown) ofthe main body 1002 to lock the secondary body 1010 in position relativeto the main body 1002. The locking mechanism 1050 also includes a distalend that may be pressed by a user to cause the proximal end to pivot sothat the boss 1054 pivots out of the aperture of main body 1002.Pivoting the boss 1054 out of the aperture of the main body 1002 unlocksthe secondary body 1010 relative to the main body 1002 and allows thesecondary body 1010 to slide or move axially within the main body 1002so as to provide an indication of an applied anchor force.

FIG. 10D illustrates a cross section view of the epicardial anchorapplication device 1000 taken along line A-A of FIG. 10C. The crosssectional view illustrates various internal components of the epicardialanchor application device 1000. Specifically, FIG. 10D illustrates thespring component 1030 positioned within main body 1002. The springcomponent 1030 is configured to engage the proximal end of the secondarybody 1010 and apply a spring force thereto. Specifically, the springcomponent 1030 includes a distal plug 1032 that engages the secondarybody 1010 to transfer or provide the spring force to the secondary body1010. The spring force is used in determining the force applied to theanchors by the epicardial anchor application device 1000. The crosssectional view also illustrates an inner shaft 1042 (FIG. 10E)positioned within the elongate shaft 1020. The inner shaft 1042 ismovable or slidable within the elongate shaft 1020 to allow the pair ofhooks 1022 and 1024 to move axially outward and inward relative to theelongate shaft 1020 and engagement pin 1025 and thereby lock and unlockthe epicardial anchor as described below.

FIG. 10E illustrates an exploded perspective view of the components ofepicardial anchor application device 1000. As shown in FIG. 10E, mainbody 1002 may be coupled with locking mechanism 1050 via a pin 1052 thatallows the locking mechanism 1050 to pivot such that boss 1054 is ableto pivot into and out of the aperture 1053 of main body 1002 as a userpresses and releases a distal portion of the locking mechanism 1050. Aspring 1008 may be positioned under the distal portion of the lockingmechanism 1050 to bias the locking mechanism 1050 toward a lockedposition in which the boss 1054 is positioned within the aperture 1053of main body 1002. The main body 1002 may also include a bottom plug1004 that may be coupled with the main body 1002 via a pin 1006. Thebottom plug 1004 provides a surface against which the spring component1030 presses as the secondary body 1010 moves axially within the mainbody 1002.

To lock the secondary body 1010 relative to the main body 1002, the boss1054 of locking component 1050 may engage with a groove or channel 1016of secondary body 1010 when the boss 1054 is positioned within theaperture of main body 1002. Frictional contact between the boss 1054 andchannel 1016 may prevent secondary body 1010 from moving axially withinthe main body 1002. In some embodiments, the secondary body 1010 may belocked relative to the main body 1002 in any axial position within mainbody 1002. In other embodiments, the secondary body 1010 may be lockedrelative to main body 1002 only in a fully extended position, such as byinsertion of boss 1054 within an aperture 1017 positioned at a distalend of groove or channel 1016. In such embodiments, boss 1054 may slidealong groove or channel 1016 to allow the secondary body 1010 to sliderelative to main body 1002 until boss 1054 engages with aperture 1017.This embodiment may allow locking mechanism 1050 to be pressed only asingle time to retract boss 1054 from aperture 1017 and position boss1054 within groove or channel 1016 and thereby enable sliding ofsecondary body 1010 within main body 1002 until aperture 1017 isreengaged by boss 1054.

FIG. 10E further illustrates the lever mechanism 1012 that may beoperated to lock and unlock an epicardial anchor. The lever mechanism1012 may include a cap that softens a force or pressure exerted on theuser's finger as the user operates lever mechanism 1012. The elongateshaft 1020 may be coupled with a distal end 1014 of secondary body 1010using a set screw or any other known coupling mechanism in the art(e.g., adhesive bonding, welding, mechanically fastening, and the like).As described herein, a pair of hooks or arms, 1022 and 1024, arepositioned at the distal end of the elongate shaft 1020. The elongateshaft 1020 includes a lumen within which an inner shaft 1042 is slidablydisposed. The inner shaft 1042 includes a pin 1044 that couples with thelever mechanism 1012 to allow the inner shaft 1042 to slide proximatelyand distally within elongate shaft 1020 as the lever mechanism 1012 isoperated by a user. A distal end of the inner shaft 1042 engages withthe pair of hooks or arms, 1022 and 1024, to allow the hooks or arms toengage with an epicardial anchor and thereby lock and unlock theepicardial anchor about a tether as the lever mechanism 1012 is operatedby a user.

The inner shaft 1042 also includes a pair of washers 1040 and 1048 thatare used to align the components within the assembly. The inner shaft1042 further includes a spring component 1046 that biases the innershaft 1042 distally relative to the elongate shaft 1020 to ensure thatthe pair of hooks, 1022 and 1024, remain unlocked or disengaged from theepicardial anchor when the lever mechanism 1012 is in an unlocked ordisengaged configuration. Stated differently, the spring component 1046ensures that the pair of hooks 1022 and 1024 do not remain locked orengaged with the epicardial anchor when the lever mechanism is operatedby a user to release the epicardial anchor.

FIGS. 11A-D illustrate an embodiment of an exemplary epicardial anchor1155. As described herein, epicardial anchor 1155 may be coupled with atension member or tether and advanced toward an external wall EW of theheart via an epicardial anchor application device or tensioning device,such as those illustrated in FIGS. 10A-E. Epicardial anchor 1155includes a lumen 1153, through which a tether is inserted. Epicardialanchor 1155 has a spring cam structure 1163, which is more fullydescribed in U.S. Patent Publication No. US2010/0016655, entitled“Cardiac Anchor Structures, Methods, and Systems for treatment ofCongestive Heart Failure and Other Conditions;” the full disclosures ofwhich are incorporated herein by reference. The spring cam 1163 allowsthe epicardial anchor 1155 to slide along a tether toward a septalanchor that is positioned adjacent the septum, but inhibits sliding ofthe epicardial anchor 1155 away from the septal anchor. As such, thespring cam 1163 effectively maintains a tissue engagement force betweenthe epicardial anchor 1155 and a septal anchor.

To engage the cam spring mechanism 1163 of epicardial anchor 1155, theepicardial anchor application device 1000 includes a pair of hooks, 1022and 1024, that are positionable around a pair of arms 1164 of epicardialanchor 1155. The pair of arms 1164 are in turn connected to, orotherwise operationally coupled with, cam spring mechanism 1163. A rod(i.e., engagement rod 1025) may be positioned between the pair of hooks,1022 and 1024, and may engage the cam spring mechanism 1163 to pivot thecam mechanism between a locked or engaged state and an unlocked orunengaged state. In operation, the pair of hooks, 1022 and 1024, may beclamped around arms 1164 so that housing 1165 is positioned betweenhooks 1022 and 1024. The lever mechanism 1012 may then be operated toretract the inner shaft 1042 and hooks, 1022 and 1024, at leastpartially within elongate shaft 1020 which causes the rod 1025 tocontact and press against housing surface 1166. Operation of the levermechanism 1012 forces the rod 1025 to push on housing surface 1166,which causes hooks 1022 and 1024 to pull on arms 1164, which in turncauses cam spring mechanism 1163 to rotate away from and/or out ofcontact with the tether of tension member (i.e., 412 of FIGS. 8F-H),thereby permitting epicardial anchor 1155 to slide both distally andproximally along tether 412 toward and away from the septal anchor(i.e., 410 of FIGS. 8G-I).

Similarly, the lever mechanism 1012 may be operated in a reverse mannerto cause the inner shaft 1042 and hooks, 1022 and 1024, to extend fromshaft 1020, which allows the arms 1164 to resiliently return to aposition in which the cam rotates into contact with the tether 412,thereby inhibiting the epicardial anchor 1155 from sliding proximallyalong the tether and away from the septal anchor 410. Arms 1164 mayfunction as a spring to bias the cam 1163 toward the tether 412 and lockepicardial anchor 1155 about the tether 412. The lever mechanism 1012may be operated from outside the patient's body to lock the epicardialanchor 1155 relative to the tether 412 or unlock the epicardial anchor1155 relative to the tether 412. In this manner, the epicardial anchorapplication device 1000 may be used to reconfigure the epicardial anchor1155 between a variable force mode that allows the epicardial anchor1155 to slide proximally and distally along the tether or tension memberand a set force mode that restricts proximal movement of the epicardialanchor 1155 along the tether or tension member.

To more accurately apply septal/external wall engagement forces within adesired range, epicardial anchor application device 1000 can engage thecam spring mechanism 1163 of epicardial anchor 1155 to reconfigure theepicardial anchor 1155 into a variable force mode in which the anchor isfree to slide in both axial directions along the tether 412. This allowsa controlled force to be applied between the tether 412 and epicardialanchor 1155 despite a beating of the heart.

The applied anchor force may be an appropriate amount of force to bringexternal wall EW and septum S into engagement while preventing migrationof the epicardial anchor 1155 and a septal anchor relative to externalwall EW and septum S. For example, the force may be sufficient so thatan inner surface of external wall EW and septum SE directly contact eachother and so that epicardial anchor 1155 and a septal anchor are securedtightly about external wall EW and septum S, but not too strong to causeepicardial anchor 1155 and/or septal anchor to be pulled through and/orinto external wall EW and/or septum S.

Referring now to FIG. 12, illustrated is a method for securing heartanchors of a heart implant device. At block 1210, a first anchor ispositioned in engagement with a first wall of the heart. The firstanchor is coupled with a tension member or tether as described herein.At block 1220, a second anchor is positioned in engagement with a secondwall of the heart. The second anchor is slidably coupled with thetension member or tether such that the second anchor may slideproximally and distally along a length of the tension member. At block1230, a tensioning device is advanced over the tension member so that adistal end of the tensioning device engages the second anchor while amain body of the tensioning device is positioned outside of the body.The tensioning device may be similar to any of the embodiments describedherein, such as the epicardial anchor application device 1000illustrated in FIGS. 10A-E. At block 1240, a desired anchor force isapplied between the tension member and the second anchor via thetensioning device so that the first anchor provides a force urging thefirst wall toward the second wall and the second anchor provides a forceurging the second wall toward the first wall. As described herein, thetensioning device provides an indication of the anchor force applied tothe second anchor by the tensioning device. At block 1250, a lockingmechanism of the tensioning device is actuated to secure the secondanchor to the tension member to restrict proximal movement of the secondanchor along the tension member.

In some embodiments, the locking mechanism of the tensioning devicereconfigures the second anchor from a variable force mode that allowsthe second anchor to slide proximally and distally along the tensionmember to a set force mode that restricts proximal movement of thesecond anchor along the tension member, and vice versa. In someembodiments, actuating the locking mechanism of the tensioning devicecauses a pair of hooks to move axially relative to a pin positioned at adistal end of an elongate shaft of the tensioning device. Movement ofthe pair of hooks relative to the pin forces the pin into engagementwith a cam component of the second anchor to lock and unlock the secondanchor.

In some embodiments, the method also includes advancing the secondanchor distally along the tension member with the tensioning device in afirst mode of operation, the first mode of operation allowing thetensioning device to engage the second anchor to urge the second walltoward the first wall without indicating the anchor force being appliedby the tensioning device, and applying the desired anchor force to thesecond anchor with the tensioning device in a second mode of operation,the second mode of operation allowing the tensioning device to providethe indication of the anchor force applied to the second anchor by thetensioning device. In some embodiments, the method may further includeactuating a mode button of a main body of the tensioning device toswitch the tensioning device from the first mode of operation to thesecond mode of operation. In some embodiments, the applied anchor forcemay include a Ventricular Contractile Force (VCF) and an additionalforce of between about 2N and about 6N. In other embodiments, theapplied anchor force may include a Ventricular Contractile Force (VCF)and an additional force of between about 3N and about 4N.

Having described several embodiments, it will be recognized by those ofskill in the art that various modifications, alternative constructions,and equivalents may be used without departing from the spirit of theinvention. Additionally, a number of well-known processes and elementshave not been described in order to avoid unnecessarily obscuring thepresent invention. Accordingly, the above description should not betaken as limiting the scope of the invention.

Where a range of values is provided, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimits of that range is also specifically disclosed. Each smaller rangebetween any stated value or intervening value in a stated range and anyother stated or intervening value in that stated range is encompassed.The upper and lower limits of these smaller ranges may independently beincluded or excluded in the range, and each range where either, neitheror both limits are included in the smaller ranges is also encompassedwithin the invention, subject to any specifically excluded limit in thestated range. Where the stated range includes one or both of the limits,ranges excluding either or both of those included limits are alsoincluded.

As used herein and in the appended claims, the singular forms “a”, “an”,and “the” include plural referents unless the context clearly dictatesotherwise. Thus, for example, reference to “a process” includes aplurality of such processes and reference to “the device” includesreference to one or more devices and equivalents thereof known to thoseskilled in the art, and so forth.

Also, the words “comprise,” “comprising,” “include,” “including,” and“includes” when used in this specification and in the following claimsare intended to specify the presence of stated features, integers,components, or steps, but they do not preclude the presence or additionof one or more other features, integers, components, steps, acts, orgroups.

What is claimed is:
 1. A heart anchor positioning device comprising: amain body; an elongate shaft having a proximal end that is coupled withthe main body and a distal end and a lumen extending between theproximal end and the distal end, wherein a tension member is insertablethrough the lumen to enable the device to be advanced over the tensionmember so that the distal end is insertable within a body adjacent theheart while the main body is positioned outside of the body; an anchorcoupling mechanism positioned at the distal end of the elongate shaft,the anchor coupling mechanism being configured to engage a heart anchorto move the heart anchor distally and proximally along the tensionmember and into engagement with a first wall of the heart to urge thefirst wall toward a second wall of the heart, the anchor couplingmechanism being configured to lock the heart anchor to inhibit proximalmovement of the heart anchor along the tension member; and a tensionindicating mechanism that is configured to indicate a force beingapplied to the heart anchor by the device.
 2. The device of claim 1,wherein the main body includes a locking mechanism that is actuatable bya user to lock the heart anchor to inhibit proximal movement of theheart anchor along the tension member and to unlock the heart anchor toallow proximal and distal movement of the heart anchor along the tensionmember.
 3. The device of claim 2, wherein the elongate shaft furthercomprises a pair of hooks, the pair of hooks being axially moveablerelative to a pin disposed at a distal end of the elongate shaft,wherein proximal movement of the pair of hooks relative to the pinengages the pin with a cam component of the heart anchor to unlock theheart anchor.
 4. The device of claim 1, wherein the tension indicatingmechanism is operable in a first mode and a second mode, wherein in thefirst mode the tension indicating mechanism allows the device to engagethe heart anchor to urge the first wall toward the second wall withoutindicating the force being applied by the device, and wherein in thesecond mode the tension indicating mechanism indicate the force beingapplied to the heart anchor by the device.
 5. The device of claim 4,wherein in the first mode the elongate shaft is stationary relative tothe main body as the force is applied to the heart anchor by the device,and wherein in the second mode the elongate shaft is moveable axiallyrelative to the main body as the force is applied to the heart anchor bythe device.
 6. The device of claim 5, wherein the elongate shaft iscoupled to a secondary body that is disposed within the main body, thesecondary body engaging a spring component positioned within the mainbody that allows the secondary body to move axially within the main bodyin the first mode, and wherein the main body includes a button componentthat is actuatable by a user to switch the tension indicating mechanismfrom the first mode to the second mode to inhibit axial movement of thesecondary body within the main body.
 7. The device of claim 6, whereinthe secondary body further comprises indicia that indicates the forcebeing applied to the heart anchor by the device as the secondary body ismoved axially relative to the main body.
 8. A method for securing heartanchors of a heart implant device, the method comprising: positioning afirst anchor in engagement with a first wall of the heart, the firstanchor being coupled with a tension member; positioning a second anchorin engagement with a second wall of the heart, the second anchor beingslidably coupled with the tension member so that the second anchor mayslide proximally and distally along a length of the tension member;advancing a tensioning device over the tension member so that a distalend of the tensioning device engages the second anchor while a main bodyof the tensioning device is positioned outside of the body; applying adesired anchor force between the tension member and the second anchorvia the tensioning device so that the first anchor provides a forceurging the first wall toward the second wall and the second anchorprovides a force urging the second wall toward the first wall, whereinthe tensioning device provides an indication of the anchor force appliedto the second anchor by the tensioning device; and actuating a lockingmechanism of the tensioning device to secure the second anchor to thetension member to restrict proximal movement of the second anchor alongthe tension member.
 9. The method of claim 8, wherein actuating thelocking mechanism of the tensioning device reconfigures the secondanchor from a variable force mode that allows the second anchor to slideproximally and distally along the tension member to a set force modethat restricts proximal movement of the second anchor along the tensionmember.
 10. The method of claim 9, wherein actuating the lockingmechanism of the tensioning device moves a pair of hooks axiallyrelative to a pin positioned on a distal end of an elongate shaft of thetensioning device, wherein movement of the pair of hooks relative to thepin engages the pin with a cam component of the second anchor.
 11. Themethod of claim 8, further comprising: advancing the second anchordistally along the tension member with the tensioning device in a firstmode of operation, the first mode of operation allowing the tensioningdevice to engage the second anchor to urge the second wall toward thefirst wall without indicating the anchor force being applied by thetensioning device; and applying the desired anchor force to the secondanchor with the tensioning device in a second mode of operation, thesecond mode of operation allowing the tensioning device to provide theindication of the anchor force applied to the second anchor by thetensioning device.
 12. The method of claim 11, further comprisingactuating a mode button of a main body of the tensioning device toswitch the tensioning device from the first mode of operation to thesecond mode of operation.
 13. The method of claim 8, wherein the appliedanchor force comprises a Ventricular Contractile Force (VCF) and theadditional force comprises a force of between about 2N and about 6N. 14.The method of claim 8, wherein the applied anchor force comprises aVentricular Contractile Force (VCF) and the additional force comprises aforce of between about 3N and about 4N.
 15. A system for securing heartanchors of a heart implant device comprising: a tension member having afirst end and a second end; a first anchor coupled with the tensionmember at the first end, the first anchor being configured for anchoringengagement with a first wall of the heart; a second anchor slidablycouplable with the tension member, the second anchor having a variableforce mode that allows the second anchor to axially slide proximally anddistally along the tension member and also having a set force mode thatinhibits proximal movement of the second anchor along the tensionmember, the second anchor being configured for anchoring engagement witha second wall of the heart; and a tensioning device configured to:engage the second anchor and apply an anchor force to the second anchor,provide an indication of the anchor force being applied to the secondanchor by the tensioning device, and switch the second anchor from thevariable force mode to the set force mode and vice versa.
 16. The systemof claim 15, wherein the tensioning device is operable in a first modethat allows the tensioning device to engage the second anchor and applythe anchor force without providing an indication of the anchor force,and the tensioning device is operable in a second mode that allows thetensioning device to provide the indication of the anchor force appliedto the second anchor by the tensioning device.
 17. The system of claim15, further comprising: a tissue penetrating device having an elongateshaft and a lumen extending between a proximal end and a distal end ofthe elongate shaft; a first needle disposed within the lumen of theelongate shaft and extendable therefrom between a first configuration,in which the first needle is substantially aligned with an axis of thelumen, and a second configuration, in which the first needle curves awayfrom the axis of the lumen; and a second needle disposed within a lumenof the first needle and extendable therefrom to penetrate the first wallor second wall of the heart.
 18. The system of claim 15, furthercomprising a cannula or trocar through which an elongate shaft of thetensioning device is inserted to engage a distal end of the tensioningdevice with the second anchor while a main body of the tensioning deviceremains positioned outside the body.
 19. The system of claim 18, whereinthe elongate shaft comprises a lumen through which the tension member isinserted to allow the tensioning device to advance over the tensionmember through the cannula or trocar.
 20. The system of claim 15,wherein the tensioning device further comprises indicia that indicatesthe force being applied to the second anchor by the tensioning device.